Medical device and monitoring method for monitoring concentration of analyte in bodily fluid

Abstract

The present disclosure describes a medical device and a monitoring method for monitoring the concentration of an analyte in a bodily fluid, the medical device being connected to a bodily fluid circulation device and a conduit and configured to monitor the concentration of an analyte in a bodily fluid flowing through the bodily fluid circulation device, the medical equipment comprises a tube body, a first connector arranged at the first end of the tube body and connected with the body fluid circulation equipment, a second connector arranged at the second end of the tube body and connected with the catheter, and an analyte monitoring device located on the tube body and used for monitoring the concentration of analytes in the body fluid. The analyte monitoring device includes a sensor extending from a bottom of the housing into the tube and in contact with the bodily fluid, a housing engaged with the tube, and electronics disposed within the housing. Based on the invention, the concentration of the analyte in the body fluid can be directly monitored, so that the convenience of monitoring the concentration of the analyte can be improved.

Description

Technical Field

[0001] The present disclosure relates generally to the biomedical industry, and more particularly to a medical device and a monitoring method for monitoring the concentration of an analyte in a body fluid. Background Art

[0002] The extracorporeal circulation system and dialysis device are two common types of equipment that draw body fluids out of the body for processing and then return them to the body. In special medical scenarios, the human body needs to be intervened by an extracorporeal circulation system or a dialysis device to maintain the functioning of the body. In the process of using these two types of equipment, it is also necessary to continuously monitor various indicators in the human body so that the human body can be adjusted accurately and timely to maintain the stable functioning of the human body. For patients with diabetes who need to use the above-mentioned equipment, it is even more necessary to continuously monitor the concentration of glucose in the body when using the above-mentioned equipment.

[0003] At present, a common solution to the above requirements is to integrate a continuous analyte monitoring system into the above two types of medical devices. For example, Patent Document 1 with Publication No. CN114616004A discloses a dialysis system with continuous glucose monitoring, wherein the system has a dialyzer, a control unit and a sensor. Patent Document 1 requires that the components of the continuous glucose monitoring system be integrated into the dialysis device.

[0004] However, the sensors of the current continuous analyte monitoring system have a shorter service life than other components of the extracorporeal circulation system and the dialysis device. If the continuous analyte monitoring system is integrated into the above-mentioned medical equipment, it is possible to increase the use cost and maintenance cost of the above-mentioned medical equipment in the above-mentioned special medical scenarios, which may be detrimental to the use of the above-mentioned medical equipment. Summary of the invention

[0005] The present disclosure is proposed in view of the above-mentioned state of the prior art, and its purpose is to provide a medical device and a monitoring method for monitoring the concentration of an analyte in a body fluid with lower use cost and maintenance cost.

[0006] To this end, the first aspect of the present disclosure provides a medical device for monitoring the concentration of an analyte in a body fluid, wherein the medical device is connected to a body fluid circulation device and a catheter and is configured to monitor the concentration of an analyte in the body fluid flowing through the body fluid circulation device, and is characterized in that the medical device includes a tube body, a first connector disposed at a first end of the tube body and connected to the body fluid circulation device, a second connector disposed at a second end of the tube body and connected to the catheter, and an analyte monitoring device located on the tube body and used to monitor the concentration of an analyte in the body fluid, wherein the analyte monitoring device includes a sensor, a shell, and an electronic device disposed in the shell, wherein the sensor extends from the bottom of the shell into the tube body and contacts the body fluid, wherein the shell is engaged with the tube body.

[0007] In the first aspect of the present disclosure, a body fluid circulation device and a catheter can be accessed using a first connector and a second connector, and the sensor can contact the body fluid in the tube body, thereby being able to directly monitor the concentration of the analyte in the body fluid, thereby being able to improve the convenience of monitoring the concentration of the analyte. In addition, the medical device accessed to the body fluid circulation device and the catheter can monitor the concentration of the analyte in the body fluid outside the body fluid circulation device, without the need to be integrated with the body fluid circulation device, thereby being able to have lower use costs and maintenance costs. In addition, the engagement of the shell and the tube body can make the medical device have a higher sealing performance, thereby being able to reduce the possibility of external contamination and leakage, and improving the safety of the medical device when in use.

[0008] In addition, in the device involved in the first aspect of the present disclosure, optionally, the shell and the tube body are joined at the connection between the shell and the tube body by ultrasonic welding. In this case, using ultrasonic welding to join the shell and the tube body can increase the sealing between the shell and the tube body.

[0009] In addition, in the device involved in the first aspect of the present disclosure, optionally, the housing and the tube body have a hole at the connection, and the sensor extends into the tube body through the hole. In this case, the hole can facilitate the sensor to pass through and enter the tube body, thereby reducing the process difficulty.

[0010] In addition, in the device involved in the first aspect of the present disclosure, optionally, the material of the tube body is the same as that of the catheter, and the material of the shell is a rigid material. In this case, the tube body is made of the same material as that of the catheter, which can make the tube body and the catheter have high compatibility and consistency, and can reduce the impact of material mutation on body fluids in the tube body. In addition, the shell is made of a rigid material, which can more firmly fix components such as sensors and electronic devices in the shell.

[0011] In addition, in the device involved in the first aspect of the present disclosure, optionally, the first connector and the second connector are detachable connectors. In this case, the use of detachable connectors can more conveniently connect and disassemble the medical device.

[0012] In addition, in the device involved in the first aspect of the present disclosure, optionally, the analyte monitoring device is a continuous analyte monitoring system, and the continuous analyte monitoring system continuously monitors the concentration of the analyte in the body fluid within a preset time period. In this case, the concentration of the analyte in the body fluid can be continuously and dynamically monitored, which can meet the need for dynamic monitoring of the analyte concentration for a long time.

[0013] In addition, in the device involved in the first aspect of the present disclosure, optionally, the analyte includes one or more of glucose, acetylcholine, amylase, bilirubin, cholesterol, chorionic gonadotropin, creatine kinase, creatine, creatinine, DNA, fructosamine, glutamine, growth hormone, hormone, ketone body, lactate, oxygen, peroxide, prostate specific antigen, prothrombin, RNA, thyroid stimulating hormone or troponin. In this case, the need for monitoring different types of analytes can be met.

[0014] In addition, in the device involved in the first aspect of the present disclosure, optionally, the electronic device includes a power supply, a signal processing element and a signal transmission element, the power supply supplies power to the sensor, the signal processing element and the signal transmission element, the signal processing element processes the first sensor signal from the sensor and obtains the second sensor signal, and the signal transmission element sends the second sensor signal to the outside in the form of wireless transmission. In this case, the power supply can enable the analyte monitoring device to operate relatively independently. In addition, the form of wireless transmission can make data transmission easier.

[0015] In addition, in the device involved in the first aspect of the present disclosure, optionally, the body fluid circulation device includes an extracorporeal circulation system and a dialysis device. In this case, it can be applied to use scenarios that require the use of an extracorporeal circulation system and a dialysis device, and has a wide applicability.

[0016] The second aspect of the present disclosure further provides a monitoring method for monitoring the concentration of an analyte in a body fluid, the monitoring method comprising obtaining the concentration of the analyte in the body fluid using the medical device as described in the first aspect of the present disclosure.

[0017] In the second aspect of the present disclosure, the body fluid circulation device and the catheter can be accessed using the first connector and the second connector, and the sensor can contact the body fluid in the tube body, thereby being able to directly monitor the concentration of the analyte in the body fluid, thereby being able to improve the convenience of monitoring the concentration of the analyte. In addition, the medical device accessed to the body fluid circulation device and the catheter can monitor the concentration of the analyte in the body fluid outside the body fluid circulation device, without the need to be integrated with the body fluid circulation device, thereby being able to have lower use costs and maintenance costs. In addition, the engagement of the shell and the tube body can make the medical device have a higher sealing performance, thereby being able to reduce the possibility of external contamination and leakage, and improving the safety of the medical device when in use.

[0018] According to the present disclosure, a medical device and a monitoring method for monitoring the concentration of an analyte in a body fluid with lower use cost and maintenance cost can be provided. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] The present disclosure will now be explained in further detail by way of example only with reference to the accompanying drawings, in which:

[0020] Figure 1 It is a schematic diagram showing the application scenario of the medical device involved in the example of the present disclosure.

[0021] Figure 2 Schematic diagram showing the structure of a medical device according to an example of the present disclosure. .

[0022] Figure 3A is a schematic diagram showing the structure of a sensor involved in an example of the present disclosure.

[0023] Figure 3B Schematic diagram showing the structure of the sensor involved in the example of the present disclosure in a bent state.

[0024] Figure 4 Schematic diagram showing the structure of a working electrode of a body fluid contacting portion of a sensor according to an example of the present disclosure.

[0025] Figure 5 Schematic diagram showing the electrochemical reactions of the nanoparticle layer and the analyte sensing enzyme layer of the analyte monitoring device according to the examples of the present disclosure.

[0026] Figure 6 is a schematic diagram showing the structure of the electronic device of the analyte monitoring device involved in the example of the present disclosure.

[0027] Figure 7 is a schematic flow chart showing the method of obtaining the concentration of an analyte in a body fluid using a medical device according to an example of the present disclosure.

[0028] Description of reference numerals:

[0029] Application scenarios…1, medical equipment…10, tube body…11, analyte monitoring device…12, sensor…121, body fluid contact part…1211, working electrode…12111, base layer…12111a, nanoparticle layer…12111b, analyte enzyme sensing layer…12111c, semipermeable membrane…12111d, biocompatible membrane…12111e, counter electrode…12112, reference electrode…12113, connection part Points...1212, first contact...1212a, second contact...1212b, third contact...1212c, substrate...1213, housing...122, electronic device...123, power supply...123a, signal processing element...123b, signal transmission element...123c, connection...13, first connector...14, second connector...15, body fluid circulation device...20, human body...30, first pipeline...40, second pipeline...50. DETAILED DESCRIPTION

[0030] Hereinafter, the preferred embodiments of the present disclosure will be described in detail with reference to the accompanying drawings. In the following description, the same symbols are assigned to the same components, and repeated descriptions are omitted. In addition, the accompanying drawings are only schematic diagrams, and the ratio of the dimensions of the components or the shapes of the components may be different from the actual ones.

[0031] It should be noted that the terms "including" and "having" and any variations thereof in the present disclosure, such as a process, method, system, product or device that includes or has a series of steps or units, are not necessarily limited to those steps or units clearly listed, but may include or have other steps or units that are not clearly listed or inherent to these processes, methods, products or devices.

[0032] The disclosed examples relate to a medical device and a monitoring method for monitoring the concentration of an analyte in a body fluid. The medical device can be used in medical scenarios where a body fluid circulation device is required. In some examples, the body fluid circulation device may refer to a device that draws body fluid from a human body out of the body for treatment and then re-injects it into the human body. The medical device for monitoring the concentration of an analyte in a body fluid can be connected to the pipeline of the body fluid circulation device, so that it can be used simultaneously with the body fluid circulation device, and the concentration of an analyte in a human body can be non-invasively monitored. In other words, the medical device can monitor the concentration of an analyte in a human body without puncturing human tissue (e.g., skin).

[0033] The medical device for monitoring the concentration of an analyte in a body fluid involved in the examples of the present disclosure (also referred to as a medical device) may also be referred to as a connection component with an analyte monitoring device, a connection component for monitoring the concentration of an analyte, etc. (also referred to as a connection component). It should be noted that each name is used to represent the medical device for monitoring the concentration of an analyte in a body fluid involved in the examples of the present disclosure, and should not be understood as limiting.

[0034] Figure 1 is a schematic diagram showing an application scenario 1 of the medical device 10 involved in the example of the present disclosure.

[0035] In some examples, such as Figure 1 As shown, in application scenario 1, the human body 30 can be connected to the medical device 10 and the body fluid circulation device 20 through the first pipeline 40 and the second pipeline 50. The medical device 10 is connected to the first pipeline 40 and the body fluid circulation device 20 at both ends. In some examples, the body fluid circulation device 20 may include an extracorporeal circulation system and a dialysis device. In this case, it can be applied to the use scenario where the extracorporeal circulation system and the dialysis device are required, and has a wide applicability.

[0036] In some examples, the body fluid of the human body 30 can be drawn from the body fluid circulation device 20 via the first pipeline 40 and the medical device 10 into the body fluid circulation device 20, and then pumped into the human body 30 via the second pipeline 50 after being processed by the body fluid circulation device 20. At this time, the body fluid flowing through the medical device 10 is the body fluid that has not been processed by the body fluid circulation device 20.

[0037] In some examples, the direction of body fluid flow may be opposite to the above description. That is, body fluid of the human body 30 is extracted through the second pipeline 50 and pumped into the medical device 10 and the first pipeline 40. At this time, the body fluid flowing through the medical device 10 is the body fluid that has been processed by the body fluid circulation device 20.

[0038] In some examples, the medical device 10 can monitor the concentration of an analyte in a body fluid flowing therethrough. In this case, the medical device 10 can non-invasively monitor the concentration of the analyte in the body fluid without being integrated with the body fluid circulation device 20, thereby reducing the burden on the human body 30 and having lower use and maintenance costs.

[0039] In some examples, when the body fluid circulation device 20 is a hemodialysis machine or an extracorporeal circulation system (e.g., extracorporeal membrane oxygenation, ECMO), the body fluid is blood, and the medical device 10 can directly monitor the concentration of the analyte in the blood. In this case, directly monitoring the concentration of the analyte in the blood can obtain a more accurate and more meaningful concentration of the analyte, which is conducive to regulating the human body 30 when using the body fluid circulation device 20.

[0040] In some examples, the analyte may include one or more of glucose, acetylcholine, amylase, bilirubin, cholesterol, chorionic gonadotropin, creatine kinase, creatine, creatinine, DNA, fructosamine, glutamine, growth hormone, hormone, ketone body, lactate, oxygen, peroxide, prostate specific antigen, prothrombin, RNA, thyroid stimulating hormone or troponin. In some examples, the analyte may also include drugs in body fluids. For example, the analyte may also be digitoxin, digoxin, theophylline, warfarin or an antibiotic (such as gentamicin, vancomycin, etc.). In this case, the need for monitoring different types of analytes can be met.

[0041] In some examples, the first pipeline 40 and the second pipeline 50 may use a medical catheter. In some examples, the material of the medical catheter may include silicone rubber, polyurethane, polytetrafluoroethylene, polyethylene, polypropylene, polyvinyl chloride, polymethyl methacrylate, polyethylene terephthalate, nylon, ABS, polycarbonate, etc. In this case, the material of the medical catheter can be selected according to different requirements in different scenarios.

[0042] In some examples, such as Figure 1 As shown, the medical device 10 can be located between the body fluid circulation device 20 and the first pipeline 40. In some examples, the medical device 10 can be located between the body fluid circulation device 20 and the second pipeline 50. In some examples, the first pipeline 40 and the second pipeline 50 can be divided into multiple sections, and the medical device 10 can be located between any two adjacent sections of the multiple sections of the first pipeline 40 and the second pipeline 50. In this case, the location of the medical device 10 can be flexibly selected.

[0043] In some examples, application scenario 1 may use more than one medical device 10. In some examples, the number of medical devices 10 that can be used in application scenario 1 may include 2, 3, 4, 5, 6, 8, 10, etc. In some examples, when multiple medical devices 10 are used, all medical devices 10 can monitor the same analyte. In this case, using multiple medical devices 10 to monitor the same analyte can help improve the accuracy of monitoring. In some examples, when multiple medical devices 10 are used, multiple medical devices 10 can monitor multiple analytes. In this case, multiple analytes can be monitored simultaneously when using the body fluid circulation device 20, and the condition of the human body 30 can be more comprehensively monitored and evaluated. It should be noted that the above enumeration of the number of medical devices 10 used is exemplary and is not a limitation on the number of medical devices 10 that can be used.

[0044] In some examples, when two medical devices 10 are used to monitor the same type of analyte, one medical device 10 can be provided on each of the first pipeline 40 and the second pipeline 50. In this case, the change in the concentration of the analyte in the body fluid after the body fluid is processed by the body fluid circulation device 20 can be monitored.

[0045] Figure 2 is a schematic diagram showing the structure of a medical device 10 according to an example of the present disclosure.

[0046] In some examples, such as Figure 2 As shown, the medical device 10 may be connected to a body fluid circulation device 20 and a catheter and may be configured to monitor the concentration of an analyte in a body fluid flowing through the body fluid circulation device 20 .

[0047] In some examples, the medical device 10 may include a tube 11, a first connector 14 disposed at a first end of the tube 11 and connected to a body fluid circulation device 20, a second connector 15 disposed at a second end of the tube 11 and connected to a catheter, and an analyte monitoring device 12 located on the tube 11 and used to monitor the concentration of an analyte in a body fluid. In some examples, such as Figure 2 As shown, the analyte monitoring device 12 may include a sensor 121, a housing 122, and an electronic device 123 disposed in the housing 122. The sensor 121 extends from the bottom of the housing 122 into the tube 11 and contacts the body fluid. The housing 122 is coupled to the tube 11.

[0048] In the present disclosure, the first connector 14 and the second connector 15 can be used to access the body fluid circulation device 20 and the catheter (that is, the first connector 14 and the second connector 15 can be used to connect the medical device 10 to the pipeline of the body fluid circulation device 20), and the sensor 121 can contact the body fluid in the tube body 11, and can directly monitor the concentration of the analyte in the body fluid, thereby improving the accuracy and convenience of monitoring the concentration of the analyte. In addition, the medical device 10 connected to the body fluid circulation device 20 and the catheter can monitor the concentration of the analyte in the body fluid outside the body fluid circulation device 20, without the need to be integrated with the body fluid circulation device 20, and can have lower use cost and maintenance cost. In addition, the connection between the shell 122 and the tube body 11 can make the medical device 10 have a higher sealing performance, thereby reducing the possibility of external contamination and leakage, and improving the safety of the medical device 10 when in use. In addition, the body fluid circulated by the body fluid circulation device 20 usually includes blood. In this case, the medical device 10 can directly monitor the glucose concentration (ie, blood sugar concentration) in the blood, thereby having higher accuracy than monitoring the glucose concentration in the tissue fluid.

[0049] In some examples, analyte monitoring device 12 may have a switch (not shown). In some examples, the switch of analyte monitoring device 12 may be disposed on housing 122, and the switch is used to turn on analyte monitoring device 12 to enable it to operate when medical device 10 is used.

[0050] In some examples, such as Figure 2 As shown, the medical device 10 may further include a connection portion 13 , with two ends of the connection portion 13 being connected to the tube body 11 and the bottom of the housing 122 , respectively.

[0051] In some examples, the shell 122 and the tube body 11 can be joined by ultrasonic welding at the connection 13 between the shell 122 and the tube body 11. In this case, the use of ultrasonic welding to join the shell 122 and the tube body 11 can increase the sealing between the shell 122 and the tube body 11, thereby increasing the safety of the medical device 10 when in use.

[0052] In some examples, the shell 122 and the tube body 11 can also be joined at the connection 13 by an adhesive. In some examples, the shell 122 and the tube body 11 can be made of the same material and formed in one piece. In some examples, the shell 122 can also be divided into a top cover and a base, wherein the base and the tube body 11 are formed in one piece, and the top cover is the same size as the base and is snapped onto the base. In some examples, the top cover and the base can also be joined together with an adhesive. In this case, different processes can be selected according to different costs and usage requirements to form an integrated shell 122 and tube body 11.

[0053] In some examples, the connection 13 may also be a separate component, and may be joined to the shell 122 and the tube body 11 at both ends by ultrasonic welding or adhesives. In some examples, the connection 13 may also be a protruding part of the tube body 11, and the connection 13 may be joined to the shell 122 at both ends by ultrasonic welding or adhesives. In some examples, similarly, the connection 13 may also be a protruding part of the shell 122, and the connection 13 may be joined to the tube body 11 at both ends by ultrasonic welding or adhesives. In some examples, the connection 13 may also be a protruding part of the base of the shell 122, and the connection 13 may be joined to the tube body 11 at both ends by ultrasonic welding or adhesives. In some examples, the connection 13 may also be formed by joining a protruding part of the shell 122 with a protruding part of the tube body 11.

[0054] In some examples, the shell 122 and the tube body 11 may have a hole at the connection 13. In some examples, the sensor 121 may extend into the tube body 11 through the hole. In some examples, the size of the hole at the connection 13 of the shell 122 and the tube body 11 may be the same. In this case, the hole can facilitate the sensor 121 to pass through and enter the tube body 11, thereby reducing the process difficulty. In this case, the connection 13 as a self-contained part of the above-mentioned different parts can further reduce the process difficulty and thus reduce the manufacturing cost.

[0055] In some examples, the connection 13 may be hollow when it is a separate component, a protruding part of the tube body 11, a protruding part of the housing 122, or a protruding part of the bottom surface of the housing 122. That is, the connection 13 may be in the shape of a small pipe. In this case, the pipe-shaped design of the connection 13 can facilitate the extension of the sensor 121 into the tube body 11.

[0056] In some examples, the connection 13 may also be solid, and the sensor 121 extends through the connection 13 into the tube body 11. In this case, better sealing can be achieved between the tube body 11 and the analyte monitoring device 12.

[0057] In some examples, the connection 13 may also be detachably connected. Specifically, the connection 13 may be connected using a detachable connection mechanism or connector. In some examples, the connection 13 may be connected using a Luer connector. In this case, the detachable connection can facilitate the replacement of the analyte monitoring device 12. In addition, the use of a Luer connector can have a higher sealing performance.

[0058] In some examples, the material of the tube body 11 may be the same as the material used for the catheter of the first pipeline 40 or the second pipeline 50. That is, if the medical device 10 is connected to the first pipeline 40, the material of the tube body 11 is the same as the material of the catheter used in the first pipeline 40; if the medical device 10 is connected to the second pipeline 50, the material of the tube body 11 is the same as the material of the catheter used in the second pipeline 50. In this case, the tube body 11 uses the same material as the catheter, which can make the tube body 11 and the catheter have high compatibility and consistency, and can reduce the impact of material mutation on the body fluid in the tube body 11.

[0059] In some examples, the material of the housing 122 may be a rigid material. In this case, the housing 122 may be made of a rigid material to more stably fix the sensor 121 and the electronic device 123 and other components in the housing 122. In addition, the rigid material may better withstand external impact, and may reduce the possibility of damage to the sensor 121 and the electronic device 123 in the housing 122 due to external impact.

[0060] In some examples, the material of the tube body 11 may be the same as that of the housing 122. In this case, the tube body 11 and the housing 122 may be made of the same material to reduce manufacturing costs.

[0061] In some examples, the first connector 14 and the second connector 15 may be detachable connectors. In this case, the detachable connectors can be used to conveniently connect and disassemble the medical device 10.

[0062] In some examples, the detachable connector (i.e., the first connector 14 and the second connector 15) may be a Luer connector. In this case, the Luer connector is a common medical pipe connector with high sealing performance, and the Luer connector can be connected with an existing medical catheter with high compatibility and sealing performance.

[0063] In some examples, the analyte monitoring device 12 may be a continuous analyte monitoring system. In some examples, the continuous analyte monitoring system may continuously monitor the concentration of the analyte in the body fluid within a preset time period. In this case, the concentration of the analyte in the body fluid can be continuously and dynamically monitored, which can meet the need for dynamic monitoring of the analyte concentration for a long time.

[0064] The structure of 120 of the analyte monitoring device 12 is described in detail below, taking the continuous glucose monitoring system as an example. It should be noted that the description of the structure of the analyte monitoring device 12 in the example of the present disclosure is not limited to the continuous glucose monitoring system, and can also be applied to other continuous analyte monitoring systems in the absence of contradictions and conflicts. The continuous glucose monitoring system is taken as an example to facilitate the explanation of the example of the present disclosure, and the present disclosure is not limited to the continuous glucose monitoring system.

[0065] Figure 3A is a schematic diagram showing the structure of the sensor 121 involved in the example of the present disclosure.

[0066] Figure 3B is a schematic diagram showing the structure of the sensor 121 involved in the example of the present disclosure in a bent state.

[0067] In some examples, such as Figure 3AAs shown, the sensor 121 may include a body fluid contact portion 1211 (i.e., a portion in contact with the body fluid in the tube body 11) and a connecting portion 1212. The body fluid contact portion 1211 may be placed in the tube body 11 in contact with the body fluid, and connected to the electronic device 123 via the connecting portion 1212. In this case, placing the body fluid contact portion 1211 in contact with the body fluid in the tube body 11 and connecting the body fluid contact portion 1211 to the electronic device 123 via the connecting portion 1212 can facilitate the transmission of a first sensing signal (described later) acquired by the body fluid contact portion 1211 to the electronic device 123.

[0068] In some examples, the body fluid contact portion 1211 of the sensor 121 may be elongated. In some examples, the body fluid contact portion 1211 may be made of a rigid material. In this case, when the body fluid contact portion 1211 is made of a rigid material, it can easily pass through the connection 13 and enter the tube body 11; and when the medical device 10 is used, the body fluid contact portion 1211 of the rigid material is less likely to bend due to the flow of body fluid, thereby reducing the impact of the bending of the sensor 121 on the accuracy of the concentration monitoring of the analyte. In other examples, the body fluid contact portion 1211 may also be made of a flexible material. In this case, when the body fluid contact portion 1211 is made of a flexible material, the resistance to the body fluid flowing in the tube body 11 is small, reducing the possibility of accumulation of substances in the body fluid in the body fluid contact portion 1211.

[0069] Figure 3B The straight line AA′ in FIG. 1 roughly shows the boundary between the body fluid contacting portion 1211 and the connecting portion 1212 of the sensor 121 .

[0070] In some examples, the body fluid contact portion 1211 may be longer than the length of the connection 13. In some examples, the body fluid contact portion 1211 may be longer than the sum of the thickness of the housing 122, the length of the connection 13, and the thickness of the wall of the tube body 11. In this case, the body fluid contact portion 1211 can extend into the tube body 11, which can facilitate contact with the body fluid in the tube body 11 for monitoring.

[0071] In some examples, the body fluid contact portion 1211 may be flat. In some examples, the body fluid contact portion 1211 may also be in the shape of an elongated rod or needle. In some examples, when the body fluid contact portion 1211 is flat, the width of the body fluid contact portion 1211 may be 2 mm or less. In addition, the width of the body fluid contact portion 1211 may also be 0.5 mm or less. In this case, the narrower body fluid contact portion 1211 has less resistance to the flow of body fluid, which can reduce the possibility of accumulation of substances in the body fluid (such as accumulation of platelets and blood cells to produce thrombi) due to obstructed flow of body fluid. However, the present disclosure is not limited to this, and the width of the body fluid contact portion 1211 may also be any other value if it is reasonable and there is no contradiction.

[0072] In some examples, the body fluid contacting portion 1211 may include a working electrode 12111 and a counter electrode 12112 (see Figure 3A ). In some examples, a sensing layer having glucose enzyme can be provided on the working electrode 12111. The body fluid contacting portion 1211 that contacts the body fluid in the tube body 11 can generate an electrochemical reaction with glucose in the body fluid through the glucose enzyme on the working electrode 12111, and form a loop with the counter electrode 12112 to generate a first sensing signal. The concentration of glucose in the body fluid can be obtained after processing, transmitting and analyzing the first sensing signal. In some examples, the electrochemical reaction can be an oxidation-reduction reaction. The first sensing signal can be an electrical signal. Furthermore, the first sensing signal can be a current signal, and it is an analog signal.

[0073] In some examples, the counter electrode 12112 may be made of platinum, silver, silver chloride, palladium, titanium, or iridium, so that the electrochemical reaction at the working electrode 12111 is not affected while having good conductivity.

[0074] In some examples, the body fluid contacting portion 1211 may also include a reference electrode 12113 (see Figure 3A ). In some examples, the reference electrode 12113 can form a known and fixed potential difference with the body fluid. In this case, the potential difference between the working electrode 12111 and the body fluid can be measured by the potential difference formed by the reference electrode 12113 and the working electrode 12111. Thus, in this case, the potential difference (also referred to as voltage) generated by the working electrode 12111 can be obtained more accurately. Thus, the electronic device 123 (described later) can automatically adjust and maintain the stability of the voltage at the working electrode 12111 according to the preset voltage value, so that the measured first sensor signal can more accurately reflect the concentration of glucose in the body fluid. In some examples, the number of reference electrodes 12113 can be one or more, for example, two.

[0075] In other examples, when the potential difference between the working electrode 12111 and the body fluid does not fluctuate much, the reference electrode 12113 may not be used. In this case, the manufacturing cost of the sensor 121 can be reduced, and thus the use cost of the medical device 10 can be reduced.

[0076] In some examples, the working electrode 12111, the counter electrode 12112, and the reference electrode 12113 can be made of the same material.

[0077] In some examples, the body fluid contacting portion 1211 may also include other blank electrodes (not shown) for improving monitoring accuracy. The blank electrodes may be configured to reduce interference of other factors in the body fluid (e.g., natural decomposition of ascorbic acid may also generate current signals) on the working electrode 12111.

[0078] In some examples, sensor 121 may include substrate 1213 (see Figure 3A ). The various electrodes as described above (including the working electrode 12111 , the counter electrode 12112 , the reference electrode 12113 , and the blank electrode, etc.) can be disposed on the substrate 1213 .

[0079] In some examples, the material of the substrate 1213 may be a flexible material. The flexible material may be substantially made of at least one of polyethylene (PE), polypropylene (PP), polyimide (PI), polystyrene (PS), polyethylene terephthalate (PET), and polyethylene naphthalate (PEN). In addition, in some examples, the flexible material may also be substantially made of metal foil, ultra-thin glass, a single-layer inorganic film, a multi-layer organic film, or a multi-layer inorganic film. In this case, when the material of the substrate 1213 is a flexible material, the resistance to the body fluid flowing in the tube body 11 is small, reducing the possibility of accumulation of substances in the body fluid on the substrate 1213.

[0080] In other examples, in some examples, the material of the substrate 1213 may also be a non-flexible material or a rigid material. The non-flexible material or the rigid material may generally include ceramics, alumina or silicon dioxide, etc., which have weak conductivity. In this case, when the material of the substrate 1213 is a non-flexible material or a rigid material, it can be easily passed through the connection 13 and enter the tube body 11; and when the medical device 10 is used, the body fluid contact portion 1211 of the rigid material is less likely to bend due to the flow of body fluid, thereby reducing the influence of the bending of the sensor 121 on the accuracy of the concentration monitoring of the analyte.

[0081] In some examples, the connection portion 1212 of the sensor 121 may be provided with one or more contacts (see Figure 3A ). For example, see Figure 3BThe sensor 121 may include a first contact 1212a connected to the working electrode 12111 via a lead, a second contact 1212b connected to the reference electrode 12113 via a lead, and a third contact 1212c connected to the counter electrode 12112 via a lead. The sensor 121 may be connected to the electronic device 123 via the first contact 1212a, the second contact 1212b, and the third contact 1212c.

[0082] In some examples, the electronic device 123 can be connected to the first contact 1212a, the second contact 1212b, and the third contact 1212c through a conductive element to connect to the sensor 121. The conductive element can be any suitable conductive material and / or structure such as an elastic conductor, a conductive rubber, a conductive probe, a conductive column, or a tab.

[0083] In some examples, the sensor 121 may not be limited to a planar probe, but may also include a linear probe, a probe having stacked electrodes or layered electrodes, and a probe having coplanar electrodes in which each electrode is disposed on the same plane.

[0084] Figure 4 is a schematic diagram showing the structure of a working electrode 12111 of a body fluid contacting portion 1211 of a sensor 121 according to an example of the present disclosure.

[0085] For some examples, see Figure 5 , the working electrode 12111 may have multiple film layers. In some examples, the multiple film layers may be stacked together. In some examples, the working electrode 12111 may have a base layer 12111a, a nanoparticle layer 12111b, an analyte enzyme sensing layer 12111c, a semipermeable membrane 12111d, and a biocompatible membrane 12111e stacked together.

[0086] In some examples, an analyte enzyme sensing layer 12111c may be provided on the base layer 12111a. In some examples, the analyte monitoring device 12 may monitor the concentration of analytes in various body fluids by changing the analyte enzyme component of the analyte enzyme sensing layer 12111c. The description of various analytes can be found above and will not be repeated here.

[0087] In some examples, when the analyte is glucose, the analyte enzyme sensing layer 12111c may contain glucose oxidase or glucose dehydrogenase. In this case, the analyte monitoring device 12 is a continuous glucose monitoring system.

[0088] In some examples, a nanoparticle layer 12111b may be disposed between the substrate layer 12111a and the analyte enzyme sensing layer 12111c. In this case, the nanoparticles contained in the nanoparticle layer 12111b can further catalyze the electrochemical reaction of the analyte, reduce the operating voltage required for the analyte reaction, and increase the reaction rate.

[0089] In the following, the analyte enzyme component of the analyte enzyme sensing layer 12111c is GO X (FAD) is used as an example to illustrate the electrochemical reaction of the analyte occurring in the nanoparticle layer 12111b and the analyte enzyme sensing layer 12111c.

[0090] Figure 5 is a schematic diagram showing the electrochemical reactions of the nanoparticle layer 12111b and the analyte sensing enzyme layer 12111c of the analyte monitoring device 12 according to an example of the present disclosure.

[0091] refer to Figure 5 , in the analyte sensing enzyme layer 12111c, when GO X When (FAD) encounters glucose in body fluids, the following reactions occur:

[0092] Glucose + GOx(FAD) → Gluconolactone + GOx(FADH2) ... Reaction formula (I)

[0093] GOx(FADH2)+O2→GOx(FAD)+H2O2……Reaction formula (II)

[0094] It can be seen from the above reaction process that oxygen (O2) is consumed in the chemical reaction. The insufficient O2 limits the reaction speed of reaction formula (II) and reaction formula (I) to the amount of O2, and the reaction with tissue glucose will be slowed down, affecting the effectiveness of sensor 121 (such as the sensitivity of sensor 121). In addition, in the above reaction process, there will be a product of H2O2 in reaction formula (II). The aggregation of H2O2 will reduce the activity of the enzyme in the analyte sensor enzyme layer 12111c, which will also affect the effectiveness of sensor 121. Therefore, by providing a nanoparticle layer 12111b between the substrate layer 12111a and the analyte sensor enzyme layer 12111c, the nanoparticle layer 12111b can be used as a catalyst to cause a decomposition reaction of H2O2. The specific reaction is as follows:

[0095] H2O2→2H + +O2+2e - ……Reaction formula (III)

[0096] Through the above reaction formula (I) to reaction formula (III), the enzyme (i.e., GO X(FAD)) reacts with glucose in body fluids continuously. In addition, by using the nanoparticle layer 12111b to catalyze the decomposition reaction of hydrogen peroxide, the reaction (III) can be accelerated and the voltage required to be applied during the reaction can be reduced, which is beneficial to improving the effectiveness of the sensor 121, extending the service life of the sensor 121, and using a lower operating voltage. In other words, through the nanoparticle layer 12111b, a high-sensitivity sensing signal of tissue glucose can be continuously obtained, the service life of the sensor 121 can be extended, and the lower operating voltage is beneficial to improving the anti-interference performance. In addition, in some examples, the nanoparticles contained in the nanoparticle layer 12111b can be carbon nanotubes. In this case, the carbon nanotubes have good conductivity, biocompatibility and catalysis, which can extend the service life of the device and make the device more compatible with the internal environment of the human body 30.

[0097] Figure 6 is a schematic diagram showing the structure of the electronic device 123 of the analyte monitoring device 12 involved in the example of the present disclosure.

[0098] In some examples, such as Figure 6 As shown, the electronic device 123 may include a power supply 123a, a signal processing element 123b, and a signal transmission element 123c.

[0099] In some examples, power source 123a can power sensor 121, signal processing element 123b, and signal transmission element 123c. In some examples, power source 123a can be a button battery. In this case, power source 123a can enable analyte monitoring device 12 to operate relatively independently.

[0100] In some examples, as described above, the sensor 121 can participate in the electrochemical reaction of the analyte in the body fluid to obtain a first sensor signal. In some examples, the first sensor signal obtained by the sensor 121 can be transmitted to the signal processing element 123b via the first contact 1212a, the second contact 1212b and the third contact 1212c. In some examples, the signal processing element 123b can process the first sensor signal from the sensor 121 and obtain the second sensor signal. In some examples, the signal transmission element 123c can send the second sensor signal to the outside in the form of wireless transmission. In this case, the form of wireless transmission can make data transmission easier.

[0101] Figure 7 is a schematic flow chart of obtaining the concentration of an analyte in a body fluid using the medical device 10 according to an example of the present disclosure.

[0102] like Figure 7As shown, the steps of signal processing and transmission of the analyte monitoring device 12 include: obtaining a first sensor signal (step S100); processing the first sensor signal to obtain a second sensor signal (step S200); sending the second sensor signal to the outside (step S300); processing the second sensor signal to obtain the concentration of the analyte in the body fluid (step S400).

[0103] In step S100 , a first sensing signal may be obtained. As described above, the first sensing signal may be obtained by the sensor 121 participating in an electrochemical reaction of an analyte in the body fluid in the tube body 11 .

[0104] In step S200, the first sensor signal may be processed to obtain a second sensor signal. In some examples, as described above, the first sensor signal is an analog signal. In some examples, the signal processing element 123b may convert the first sensor signal after receiving the first sensor signal. In some examples, the signal processing element 123b may convert the analog signal into a digital signal. That is, in some examples, the signal processing element 123b may convert the first sensor signal as an analog signal into a second sensor signal as a digital signal.

[0105] In step S300, a second sensing signal may be sent to the outside. In some examples, the second sensing signal acquired by the signal processing element 123b may be transmitted to the signal transmission element 123c. In some examples, the signal transmission element 123c may modulate the second sensing signal and send it to an external device in the form of a wireless signal. In some examples, the wireless signal sent by the signal transmission element 123c may include a wireless network (Wi-Fi) signal or a Bluetooth signal. In some examples, the signal transmission element 123c may also send a second transmission signal to an external device in a wired form.

[0106] In step S400, the second sensing signal may be processed to obtain the concentration of the analyte in the body fluid. In some examples, after receiving the second sensing signal, the external device may obtain the concentration of the analyte in the body fluid based on the second sensing signal.

[0107] In summary, in the medical device 10 and monitoring method involved in the example of the present disclosure, the first connector 14 and the second connector 15 can be used to access the body fluid circulation device 20 and the catheter, and the sensor 121 can contact the body fluid in the tube body 11, and can directly monitor the concentration of the analyte in the body fluid, thereby improving the convenience of monitoring the concentration of the analyte. In addition, the medical device 10 connected to the body fluid circulation device 20 and the catheter can monitor the concentration of the analyte in the body fluid outside the body fluid circulation device 20 without being integrated with the body fluid circulation device 20, thereby having lower use and maintenance costs. In addition, the connection between the shell 122 and the tube body 11 can make the medical device 10 have a higher sealing performance, thereby reducing the possibility of external contamination and leakage, and improving the safety of the medical device 10 when in use.

[0108] According to the present disclosure, a medical device 10 for monitoring the concentration of an analyte in a body fluid and a monitoring method are provided, which have lower use cost and maintenance cost.

[0109] Although the present disclosure is specifically described above in conjunction with the accompanying drawings and examples, it is to be understood that the above description does not limit the present disclosure in any form. Those skilled in the art may modify and change the present disclosure as needed without departing from the essential spirit and scope of the present disclosure, and these modifications and changes all fall within the scope of the present disclosure.

Claims

1. A medical device for monitoring the concentration of an analyte in a body fluid, the medical device being connected to a body fluid circulation device and a catheter and configured to monitor the concentration of an analyte in a body fluid flowing through the body fluid circulation device, characterized in that: The medical device includes a tube body, a first connector disposed at a first end of the tube body and connected to the body fluid circulation device, a second connector disposed at a second end of the tube body and connected to the catheter, and an analyte monitoring device located on the tube body and used to monitor the concentration of an analyte in the body fluid, the analyte monitoring device includes a sensor, a shell, and an electronic device disposed in the shell, the sensor extends from the bottom of the shell into the tube body and contacts the body fluid, wherein the shell is engaged with the tube body.

2. The medical device according to claim 1, characterized in that The shell and the tube body are joined at a connection point between the shell and the tube body by ultrasonic welding.

3. The medical device according to claim 2, characterized in that The shell and the tube body have a hole at the connection, and the sensor extends into the tube body through the hole.

4. The medical device according to claim 1, characterized in that The material of the tube body is the same as that of the conduit, and the material of the shell is a rigid material.

5. The medical device according to claim 1, characterized in that The first joint and the second joint are detachable joints.

6. The medical device according to claim 1, characterized in that The analyte monitoring device is a continuous analyte monitoring system, which continuously monitors the concentration of the analyte in the body fluid within a preset time period.

7. The medical device according to claim 1, characterized in that The analyte includes one or more of glucose, acetylcholine, amylase, bilirubin, cholesterol, chorionic gonadotropin, creatine kinase, creatine, creatinine, DNA, fructosamine, glutamine, growth hormone, hormones, ketone bodies, lactate, oxygen, peroxide, prostate specific antigen, prothrombin, RNA, thyroid stimulating hormone or troponin.

8. The medical device according to claim 1, characterized in that The electronic device includes a power supply, a signal processing element and a signal transmission element. The power supply supplies power to the sensor, the signal processing element and the signal transmission element. The signal processing element processes a first sensing signal from the sensor and obtains a second sensing signal. The signal transmission element sends the second sensing signal to the outside in the form of wireless transmission.

9. The medical device according to claim 1, characterized in that The body fluid circulation equipment includes an extracorporeal circulation system and a dialysis device.

10. A method for monitoring the concentration of an analyte in a body fluid, characterized in that: The monitoring method comprises obtaining the concentration of the analyte in a body fluid using the medical device as claimed in any one of claims 1 to 9.

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